Diabetes Self-Management + CGM for Type 2 Diabetes

EA
Overseen ByElizabeth A Vrany
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining a virtual diabetes self-management program, specifically The DECIDE Self-Management Program, with continuous glucose monitoring (CGM) can help adults with type 2 diabetes manage their condition more effectively. Participants will attend a 9-week online program and use CGM sensors to track blood sugar over 22 weeks. The trial aims to determine if this approach is practical and well-received by participants, potentially leading to better health outcomes. It suits those with type 2 diabetes who have high blood sugar levels and can use a smartphone. As an unphased trial, this study offers a unique opportunity to explore innovative diabetes management strategies that could enhance health and daily life.

What prior data suggests that this combination of diabetes self-management program and CGM is safe?

Research has shown that continuous glucose monitoring (CGM) is generally safe for people with type 2 diabetes. Studies have found that CGM users often experience fewer low blood sugar episodes and achieve better blood sugar control. Additionally, CGM devices are typically easy to wear and continuously track blood sugar levels without frequent finger pricks.

The DECIDE Self-Management Program aims to help people with diabetes manage their condition more effectively. Although specific safety data is not available, the program focuses on teaching skills for problem-solving and improving self-care, which can lead to better overall health and increased confidence in managing diabetes.

In summary, both CGM and the DECIDE Program have shown promise in safely helping manage type 2 diabetes.12345

Why are researchers excited about this trial?

The DECIDE Self-Management Program is unique because it combines a virtual education platform with continuous glucose monitoring (CGM) sensors, offering a comprehensive approach to managing Type 2 Diabetes. Unlike standard treatments that often rely solely on medication or periodic blood glucose checks, this program empowers patients with real-time data and personalized education, potentially improving their ability to manage their condition daily. Researchers are excited because the combination of these tools could lead to better patient engagement, improved glucose control, and a more personalized diabetes management experience.

What evidence suggests that combining the DECIDE Self-Management Program with CGM is effective for type 2 diabetes?

In this trial, participants will receive both the DECIDE Self-Management Program and continuous glucose monitoring (CGM). Research has shown that CGM can significantly aid people with type 2 diabetes. One study found that those using CGM spent 26% more time with their blood sugar levels in a healthy range. Additionally, participants using CGM experienced a drop in their A1C levels, indicating better overall blood sugar control.

Similarly, the DECIDE Self-Management Program has proven effective in helping patients manage their diabetes. Studies have shown that participants in similar programs experience significant reductions in their A1C levels, with improvements often lasting for months after completing the program. Together, these tools could offer a promising way to better manage diabetes.12367

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are interested in trying a virtual self-management program and using a continuous glucose monitor. Participants should be able to attend online sessions and wear the CGM device as instructed.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.
Suboptimal hemoglobin A1C (8.0% or greater) based on a laboratory result in the past 3 months
I am able to understand and agree to participate in this study.
See 3 more

Exclusion Criteria

I am currently receiving dialysis treatment.
Currently using CGM
Non-English speaking
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DECIDE Self-Management Program

Participants receive the 9-week, virtually delivered DECIDE Self-Management Program

9 weeks
Virtual sessions

Continuous Glucose Monitoring

Participants wear CGM sensors to track blood sugar levels during the study

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after the DECIDE program ends

3 months post-intervention
Questionnaires and blood draws at home

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Glucose Monitoring (CGM)
  • The DECIDE Self-Management Program

Trial Overview

The study tests if combining a 9-week virtual diabetes education program (DECIDE) with wearing a continuous glucose monitor for 22 weeks helps adults manage their type 2 diabetes better. The focus is on how practical and acceptable this approach is.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DECIDE Self-Management Program + CGMExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Albert Einstein College of Medicine

Collaborator

Trials
302
Recruited
11,690,000+

Citations

Type 2 Diabetes and the Use of Real-Time Continuous ... - PMC

CGM group spent 21% less time in hypoglycemia (<55 mg/dL), 23% less time in hyperglycemia (≥240 mg/dL), and 26% more time in the target (81–140 mg/dL) glucose ...

Perceived impact of continuous glucose monitor use on ...

Our T2DM respondents experienced a reduction in A1c, improved glucose control, and better overall health and quality of life from CGM use

Continuous Glucose Monitoring (CGM)

People with type 1 and type 2 diabetes who use a CGM have fewer instances of hypoglycemia and a lower A1C.

Advances in Continuous Glucose Monitoring: Clinical ...

Studies report consistent glycosylated hemoglobin reductions of 0.25%–3.0% and notable time in range improvements of 15%–34%.

Impact of continuous glucose monitoring on patient ...

This review focuses specifically on emotional and patient-reported outcomes in adults with type 2 diabetes. This meta-analysis was performed to further ...

Continuous glucose monitors (CGMs) for type 2 diabetes

CGMs are generally safe and not difficult to wear, though they are usually worn 24 hours a day and for 365 days a year. The sensors should be ...

CGM l Pros and Cons of Continuous Glucose Monitors ...

The ADA SOC 2025 recommends CGM for all individuals with Type 1 diabetes and those with Type 2 diabetes on insulin. It is also strongly recommended for pregnant ...